context: The National Medical Products Administration released a notice encouraging applications for clinically-needed overseas-marketed original drugs and generics, with qualifying applications eligible for priority review. The policy significantly simplifies requirements for rare disease drugs, reducing inspection timelines and sample requirements. The PRC has around 20 million rare disease patients, previously, many faced situations where treatments were only available abroad but not domestically.
For rare disease drugs already marketed overseas but not in the PRC, this policy encourages front-loaded inspection applications. Inspection timelines are shortened from 60 to 40 days for sample inspection only, and from 90 to 70 days when combining standard review with sample inspection. Sample requirements are reduced to one commercial-scale production batch, down from previous multi-batch, large-sample requirements.
Clinically-needed drugs, particularly rare disease treatments, will enter the PRC market faster, resolving patients' lack of treatment options and accelerating drug accessibility, said Jin Chunlin 金春林 Shanghai Health Development Research Centre.
Jin identified six key provisions in the new policy
- establishing pre-submission communication channels allowing applicants to reach consensus with the National Medical Products Administration Centre for Drug Evaluation on data utilisation and priority review before formal applications
- accepting overseas clinical data with conditional approval, potentially waiving domestic clinical trials and significantly shortening time-to-market
- special inspection arrangements for rare disease drugs, including reducing minimum sample quantities to two times commercial batch size rather than three times
- risk-based approaches to registration and post-market inspections, including remote inspection options
- temporary import channels for drugs still under review but clinically urgent
The policy encourages global simultaneous R&D and applications in the PRC, addressing a longstanding pain point where global new drugs reached the PRC market three-to-five years after Europe and the US, Jin noted. By accepting overseas clinical data and shortening inspection processes, companies can save time and costs from repeating clinical trials domestically, he added.
Jin cautioned that implementation challenges remain. Supporting measures need refinement, particularly medical insurance linkage—if newly approved drugs cannot be included in insurance coverage promptly, patient accessibility will be significantly discounted, he said. For rare disease drugs specifically, commercial sustainability remains difficult given small patient populations and high R&D costs, Jin observed.
The policy also tests regulatory capacity. Clinical trial applications must be decided within 30 days, and sample inspection timelines are compressed. This places higher demands on regulatory staffing and expertise, Jin noted. He called for clearer official guidance on clinical urgency standards, applicable disease areas and dynamic adjustment mechanisms to stabilise industry expectations.